The present invention relates generally to systems and methods for tracking usage and preventing errors in the delivery of medical treatments. More particularly, the present invention relates to systems and methods for monitoring the delivery of medications to patients, such as over-the-counter and prescription drugs, as well as to systems and methods for insuring that such medications are administered to patients at prescribed times. Among other benefits, the present invention may save the lives of patients by reducing medical errors. The present invention also may reduce exposure of hospitals and other medical professionals to liability for errors arising from improper delivery of medications.
The explosive developments in medical treatment relating to drugs have created a costly and high risk drug management environment for the patient. A 1995 study published in the xe2x80x9cArchives of Internal Medicinexe2x80x9d estimates that $76 billion is spent each year in the U.S. on extra doctor visits and hospitalization because people do not take their medication properly. In addition, a 1999 study by the National Academy of Science, Institute of Medicine, describes errors made in the hospitals which threaten patient""s health. The study estimated that 98,000 patients die each year because of medical mistakes. Prescription drug errors are one of the major areas where mistakes are made.
Unit-dose blister type packaging for prescription drugs is one of the fastest growing package formats and is projected to be at 40% penetration in the U.S. market by 2003. Blister packages are already the dominant prescription drug package format in Europe with 85% penetration. Some of the reasons behind this growing use of blister packaging are: (i) product integrity being maintained throughout out the drug life cycle, (ii) better product protection to insure quality and efficacy of the drug, (iii) better tamper evidencing and child resistance, and (iv) improved patient compliance in that unit-dose blister packaging gives patents a clearly marked individual dosage.
The medication that can be contained in such packaging is diverse. Many of the medications, however, have chemical sensitivity to heat, humidity, light, or cold. Over-exposure to these environmental conditions can reduce the potency of efficacy of the medication. As dosing (the amount of a medication prescribed) may be required to be within a specific range, the potency or efficacy of the medication must be accurately known to allow the correct amount to be taken by the patient. If the efficacy of a medication has been reduced, such as through over-exposure to sunlight, a prescribed dosage which assumes an efficacy associated with recently produced medication may be insufficient.
In order to avoid problems associated with environmental exposure and normal chemical breakdown over time, medication manufacturers have determined expiration dates at which it must be assumed that the medication has lost sufficient efficacy to prevent its use on a patient. The expiration date must rely on a worst-case estimate of when the medication loses efficacy, such that large amounts of medication are disposed of once the expiration date has been met. Organizations which must stockpile quantities of medication for use frequently must dispose of stock due to the expiration date, while the storage method used when stock-piling the medication has prevented the worst-case loss of efficacy.
In order to provide for the monitoring of medications, two controlling factors are the ability of a transceiver associated with a medication package to communicate with a master transceiver; and the ability of the package to have an energy source with a sufficient duration to provide for monitoring through the life of the medication contained in the packaging
The present invention is directed to a medication package and system for assisting in the management of the delivery of medications. The system includes a package that includes one or more unitary-dose cells. Each cell is sealed by a breakable closure. A user gains access to medication in a cell by rupturing the closure associated with the cell. A severable conductor is positioned proximate to each cell. The severable conductor associated with a given cell is cut upon rupture of the closure associated with the given cell, resulting in a loss of continuity through the conductor.
In a first embodiment, the medication package is provided with an attachable circuitry unit to create a medication management system. The unit includes a connector for attaching the medication package to circuitry contained in the unit. The circuitry in the unit allows the accessing of the cell or cells of the package to be monitored. Memory may be included in the unit to allow acquired data to be stored. A processor and clock may be included to allow recording of the time at which a cell or cells was accessed. Alternately, the processor may be used to determine when a cell should be accessed for medication to be taken. A signal such as a buzzer or light may be included to indicate an event to a user, such as when medication should or should not be taken. An RF transceiver may be included for communicating data from the unit and instructions or data to the unit.
In another embodiment, the system of the present invention is a blister package that includes a plurality of cells arranged in a grid. Each of the cells is sealed by a breakable closure and holds a unit-dose of a medication. A user gains access to the medication in a given cell by rupturing the breakable closure associated with the given cell. A severable conductor is positioned proximate to each breakable closure. The severable conductor associated with a given cell is cut when the breakable closure associated with the given cell is ruptured to allow access to the medication therein. A computer chip may be affixed to the blister package and electrically connected to the severable conductors. The computer chip senses the accessing of each cell in the package by monitoring for loss of continuity in individual conductors due to cutting of each of the severable conductors. An RF transmitter is affixed to the blister package and coupled to the computer chip. The RF transmitter may send information corresponding to usage of each of the medication stored in the blister package to a remote information transceiver.
In another embodiment, the RF transmitter sends information corresponding to usage of medication stored in one cell in the blister package to the remote information transceiver upon cutting of the severable conductor associated with the one cell.
In addition, the package may include a memory that stores time values, wherein each of the time values represents a time when medication stored in one cell in the blister package is due to be taken by a patient. Upon receipt of the information corresponding to usage of medication stored in one cell in the blister package, the memory stores a further time value representing a time when medication stored in one cell in the blister package was actually taken by the patient. In a particularly preferred embodiment, the remote information transceiver generates an alarm if the time when medication stored in one cell in the blister package is due to be taken by a patient passes before the remote information transceiver receives a signal indicating that medication stored in a cell in the blister package was actually accessed by the patient.
An RF receiver is also preferably affixed to the blister package and coupled to the computer chip. The RF receiver receives information corresponding to an expiration date of each of the medications stored in the blister package, and the computer chip stores such information. The expiration date information may, for example, be transmitted to and stored in the memory at the time of shipment of the blister package from a manufacturer or distributor. At a later time (e.g., at the time the blister pack is dispensed from a pharmacy), the RF transmitter may send the information corresponding to the expiration date to the remote information transceiver. In this embodiment, the remote information transceiver generates a further alarm if the time when medication stored in one cell in the blister package is due to be taken by a patient exceeds the expiration date information associated with the blister package.
In accordance with a further aspect, the remote information transceiver comprises a plurality of local RF sensors each of which is located is an individual hospital room, and a central computer coupled to each of the plurality of local RF sensors. The system also includes a plurality of portable data monitoring units each of which is coupled by a wireless link to the central computer. Each of the portable data monitoring units is associated with a medical professional who is responsible for administering medication to a group of one or more patients. In this embodiment, each alarm generated by the remote information transceiver is associated with a particular patient, and the remote information transceiver sends each such alarm to the portable data monitoring unit associated with the medical professional who is responsible for administering medication to the particular patient.
In accordance with a still further aspect, the package of the present invention further includes a temperature sensor coupled to the computer chip. The temperature sensor sends information corresponding to an ambient temperature proximate the package to the computer chip. An alarm is generated if the ambient temperature sensed by the temperature sensor exceeds a first threshold or is below a second threshold. The first and second thresholds correspond, for example, to the upper and lower temperature limits to which the pharmaceuticals in stored in the package may be exposed without losing efficacy. The alarm may be generated from information stored in the package memory (i.e., the allowable temperature limits), or alternatively, by the remote information transceiver based on similar information stored therein. As a result of the alarm, a patient or a medical professional responsible for administering medication to a patient will be immediately informed that the packaged medication should not be used if the package has been subjected to temperature conditions that are outside acceptable limits.
In accordance with a still further aspect, the package of the present invention includes a humidity sensor coupled to the computer chip. (The humidity and temperature sensor may be formed from an integrated unit on the package). The humidity sensor sends information corresponding to humidity proximate the medication cell to the computer chip. An alarm is generated if the ambient humidity sensed by the humidity sensor exceeds a first threshold or is below a second threshold. The first and second thresholds correspond, for example, to upper and lower humidity limits at which the exposure results in the loss of efficacy of medication stored in the package. The alarm may be generated from information stored in the package memory (i.e., the allowable humidity limits), or alternatively, by the remote information transceiver based on similar information stored therein. As a result of the alarm, a patient or a medical professional responsible for administering medication to a patient may be informed that the packaged medication should not be used if the package has been subjected to humidity conditions that are outside acceptable limits.
In accordance with a further embodiment, the package includes a light sensor, which is preferably coupled to the computer chip. The light sensor may monitor the amount of light to which medications within the blister pack are subjected. A warning may be generated if the cumulative amount of light to which the medication is exposed exceeds a threshold value such that the efficacy of the medication may be jeopardized. The warning may be generated based on information stored in the package memory, or, alternatively, by the remote information transceiver based on similar information stored therein. As a result of the alarm, a patient or a medical professional responsible for administering medication to a patient will be immediately informed that the packaged material should not be used if the package has been subjected to a cumulative amount of light that is outside of acceptable limits.
In accordance with a still further embodiment, the package may include an electronic circuit functioning to monitor and store data associated with environmental conditions including the humidity environment, the temperature environment, and the light environment. The monitored information of environmental conditions and severable conductor status may be transmitted to a drug dispensing and monitoring authority such as a Hospital or Pharmacy via an RF transceiver. The RF antenna, electronic monitoring function, and severable conductor monitors may be located on the patient medication package as surface mount type of devices. The electronic monitoring circuit may be implemented as one or more digital, analog, or mixed mode ASICs, FPGAs, or LSI and VLSI integrated circuits. The temperature, humidity, and light sensors may be connected to the electronic monitoring circuit such that they can measure environmental exposure to levels in excess of given limits over time.
The electronic components may be mounted on either one or both sides of the patient medication package. When electronic components are mounted on both sides of the medication container, through-hole interconnects or edge interconnects may be used to electrically interconnect the circuitry of one side to that of another.
In a still further embodiment, the medication package of the current invention may be provided with a power supply comprising a plurality of layers applied to one or both of the surfaces of the medication package. The power supply may comprise a flat battery applied to one side of the package, such as using a pressure sensitive adhesive, or may comprise a plurality of layers which comprise the cell being applied to the medication packaging using printing methods to apply electrodes and electrolyte mediums.
In a still further embodiment, the medication package of the present invention may further be provided with an antenna extending over a portion of the medication packaging to increase the ability of the medication package to receive and transmit RF communications from a remote transceiver. The antenna may be formed by applying a conductive material to one side of the medication packaging in areas separate from the cells used to contain medication. The application of the antenna to the surface may be accomplished prior to the forming of the medication cells, such as by using a hot thermoforming technique. Accordingly, the reverse side of the medication package may contain a power supply over a portion of the surface area of the side, while a further portion contains a printed antenna to improve communications efficiency.
These and other advantages and benefits of the present invention will become apparent from the detailed description and the claims below.